FDA.reportPublic FDA data

TRUWAVE

Primary DI
00690103144468
Brand
TRUWAVE
Company
Edwards Lifesciences LLC
Model
55UF130
Catalog number
55UF130
Device description
UNIFLOW FLUSH DEVICE, 30ML/HR
Published
2016-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXOTRANSDUCER, PRESSURE, CATHETER TIP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142749000TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC2015-01-18DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50690103144463PackageGS120In Commercial Distribution
00690103144468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010314446350690103144463
00690103144468006901031444686901031444680690103144468

GMDN Terms#

Term, Definition table
TermDefinition
Pressure transducer dome, single-useA sterile plastic housing that connects together with an external pressure transducer (not included),, forming a measuring compartment. The transducer is influenced by the pressure of the medium, e.g., blood directly from a patient, that is channelled into the compartment, thereby creating the signals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DRY PLACE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103220636ESHEATH OPTIMA14000ES16A14000ES162025-10-09
00690103219784Edwards 23F Guide Sheath9880GS9880GSA2026-01-30
00690103219562Edwards EVOQUE Loading System9850LSB9850LSBUS2025-07-09
00690103219579Edwards EVOQUE Stabilizer9850SZUS9850SZUS2025-07-09
00690103220629ESHEATH OPTIMA INTRODUCER SET (14F)14000ES1414000ES142025-05-07
00690103217773Edwards EVOQUE Loading System9850LSAUS9850LSAUS2024-10-03
00690103217483EVOQUE9850PTUS9850PTUS2024-02-07
00690103217490EVOQUE9850LSUS9850LSUS2024-02-07
00690103217506EVOQUE9850DKUS9850DKUS2024-02-07
00690103217513EVOQUE9850SBUS9850SBUS2024-02-07
00690103217476EVOQUE9850BAUS9850BAUS2024-02-06
00690103215465Edwards eSheath+ Introducer set914ESP914ESPA2021-10-06
00690103215472Edwards eSheath+ Introducer set916ESP916ESPA2021-10-06
00690103182262EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T262015-09-24
00690103182279EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T282015-09-24
00690103182286EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T302015-09-24
00690103182293EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T322015-09-24
00690103182309EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T342015-09-24
00690103182316EDWARDS MC3 TRICUSPID ANNULOPLASTY RING4900T4900T362015-09-24
00690103190816Thruport Systems Introducer Sheath KitIS19AIS19A2016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540184010127OptoMonitorOpsens IncDXO2026-09-30
07540184020027OptoMonitorOpsens IncDXO2026-09-30
07540184020034OptoMOnitorOpsens IncDXO2026-09-30
07540184020041OptoMonitorOpsens IncDXO2026-09-30
07540184020058OptoMonitorOpsens IncDXO2026-09-30
07540184020065OptoMonitorOpsens IncDXO2026-09-30
07540184020072OptoMonitorOpsens IncDXO2026-09-30
00885403533665TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543282TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543299TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543305TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543312TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543428TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543435TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543459TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543466TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543473TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543480TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544128TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544135TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544142TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544159TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544166TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544180TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544432TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544470TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544487TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544494TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544500TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544524TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18